Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix

Inclusion criteria

• Informed Consent signed by the subject
• Age ≥ 18 years
• Willingness to sign informed consent and to participate in the study
• Single tooth gap or extended edentulous space in the lower or posterior jaw including a pontic site with a soft tissue deficiency.
• Tooth gap of ≥ 8 mm.
• Presence of natural or artificial opposing dentition
• Sufficient vertical interocclusal space of an implant restoration (7mm)
• Bounded by natural and periodontally stable teeth
• Treatment plan must include tooth replacement with an implant or tooth-supported fixed dental prosthesis.

Exclusion criteria

• Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance with the protocol
• Severe bruxism, clenching habits, or presence of oro-facial pain
• Uncontrolled diabetes mellitus (HbA1c >7.0)
• Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Any active oral or systemic acute infections
• Currently receiving chemo- or radiotherapy or a history of radiotherapy in the head and neck area
• Severe hematologic disorders
• Any other diseases or medications that may compromise normal wound healing
• Pregnancy or nursing mother
• Contraindications and limitations of the MD as described in the instructions for use: during pregnancy or lactation, children, presence of acute infection in the surgical area, patients with known sensitivity to porcine material or collagen allergies.
• Vulnerable subjects
• Known or suspected non-compliance
• Drug or alcohol abuse
• Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc.
• Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
• Enrolment of the PI, his/her family members, employees and other dependent persons